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1. PEDIATRIC MEDICATION
Ravish Yadav

2. Contents • Introduction
• Importance Of Pediatric Drug Handling
• The Normal Child
Pharmacokinetic of Children
A, D, M, E
Monitoring Parameters
Drug Therapy in Children
Dose Calculation
Appropriate Dosage form and route
Diseases condition
Adverse reaction in Therapy
2

3. Introduction
3
• Pediatric means..
• As per ICH (2000) ,Childhood is divided in..
Age:- Up to 28
days
(Neonate)
Age:- 2- 11
years
(Children)
Age:- 1- 24
months
(Infants)
Age:- 12-18 years
(Adolescents)

4. Pharmacokinetics:
• There is high importance of clinical pharmacokinetics in
optimization of drug therapy.
• Drugs that are safe and effective in one group of
pediatric patients may be ineffective or toxic in
another, so an understanding of variability in drug
disposition is essential if children are to receive
rational and appropriate drug therapy.
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A
D
M
EABSORBTION
DISTRIBUTION
METABOLISM
EXCRETION

5. • Two factors affecting the absorption of drugs from the
G.I. tract are pH-dependent passive diffusion and gastric
emptying time. Other is G.I. tract enzyme activity.
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PH
• Premature Infants- Elevated pH (More
than Infant)
• Infant- Range from 6-8
Gastric
Emptying
• Infants/Noenate:- Prolonged gastric
emptying time. But lower peristaltic
movement than older child and adults.
A

6. • In premature infants, higher serum concentrations of
acid-labile drugs—such as penicillin, ampicillin and
nafcillin—and lower serum concentrations of a weak
acid such as phenobarbital can be explained by higher
gastric pH.
• Gastric emptying time:-
• Gastric emptying time is delayed in infants and
reaches adult levels by 6 to 8 months of age.
• Drugs that are absorbed primarily in the stomach may
be absorbed more completely than anticipated. In the
case of drugs absorbed in the small intestine,
therapeutic effect may be delayed.
6
A

7. • Gastrointestinal enzyme activities:-
• It is lower in the newborn than in the adult. Activities of
amylase and lipase, beta-glucuronidase, and glutathione
peroxidase enzymes are low in infants up to 4 months of
age.
• Absorption from Intramuscular route:-
• less predictable absorption in infant
• Examples like Diazepam Rapid Absorption ,
Phenobarbital Poor absorption
7
A

8. • Absorption from Skin :-
• Percutaneous absorption may be increased in neonate
because of an underdeveloped epidermal barrier (stratum
corneum) and increased skin hydration.
• Absorption from Rectal route :-
• The rectal route of administration can be useful in
infants or children who are unable to take oral
medication.
• The mechanism of rectal route absorption is probably
similar to that of the upper part of GI tract, despite
differences in pH, surface area and fluid content.
8
A

9. • Drug distribution is determined by
• Physicochemical properties of the drug itself (pKa, molecular
weight, partition coefficient,etc…)
• Physiologic factors specific to the patient.
• So, variable aspect is the physiologic functions such
as
• Total Body Water
• Plasma Protein binding of drug
• Volume of Distribution
9
D

10. 10
D
Total Body
Water
• 94% in the fetus, 85% in premature
infants, 78% in full-term infants, and
60% in adults.
Plasma
Protein
Binding
• Less in Newborn and infants
VD
• The decrease in plasma protein binding
of drugs can increase their apparent
volumes of distribution

11. • Drug metabolism is substantially slower in infants
compared with older children and adults.
• Less maturation of various pathways of metabolism
within a infant.
• E.g. :- sulfation pathway is well developed but the
glucuronidation pathway is undeveloped in infants.
• The cause of the tragic chloramphenicol-induced
gray baby syndrome in newborn infants is a
decreased metabolism of chloramphenicol by
glucuronyl transferases to the inactive glucuronide
metabolite.
11
M

12. • Because of decreased metabolism, doses of such
drugs as theophylline, phenobarbital, phenytoin, and
diazepam should be decreased in premature infants.
12
M

13. • The processes of glomerular filtration, tubular
secretion, and tubular reabsorption determine
the efficiency of renal excretion. These
processes may take several weeks to 1 year after
birth to develop fully.
• Glomerular filtration rate is about 2–4 mL/min
• In infants, if possible then avoid Chloramphenicol
and Amino glycoside, because their metabolites
are accumulated due to immature function of
kidney.
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E

14. 14
Drug therapy in pediatrics
1. Dose calculation
2. Choice of dosage form
3. Disease Condition
4. Adverse reaction
5. Counseling

15. 1. Dose calculation :-
• Height and Wt growth are rapidly changing
factors in childhood, which also influence
significantly some p’kinetic parameters. So, this
factors should be considered during therapy. So
dose calculation is needed.
• Doses should be obtained from pediatric book
for children.. For example, In india IAP-Drug
formulary is reliable source for pediatric
practice and their important drugs.
• For many years, pediatric dosage calculations
used pediatric formulas such as Fried’s rule,
Young’s rule, and Clark’s rule. These formulas are
based on the weight of the child in pounds, or on
the age of the child in months, and the normal
adult dose of a specific drug.
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16. 1) Young’s Rule :- (based on age)
Pediatric dose =
Age × Adult Dose
Age + 12
2) Fried’s Rule :- (Age adjustment for infants)
Infant Dose =
Age × Adult Dose
150
3) Clark’s Rule :- (based on body weight)
Pediatric Dose =
Weight × Adult Dose
150
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17. 2. Choice of Dosage form :-
• Other routes like….
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Oral Route
• Tablets are less convenient
• Liquid preparation are easy to administer in
accurate dose and to form in desirable dose
by dilution
Parenteral Route:-
• Site of Access
• Safety from fluid overload
• Aware about Excipients

18. • Dose regimrn selection :-
Factors to be considered when selecting a drug
regimen or rout of administration for a pediatric
patient are…
• Age/Weight/Surface area
• Assess the appropriate dose
• Assess the most appropriate interval
• Assess the route of administration
• Consider the expected response and monitoring parameters
• Interactions
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19. 19
3. Diseases condition :-

20. Liver disease :-
• Drugs with a high hepatic extraction ratio (>0.7; such
drugs include morphine, meperidine, lidocaine, and
propranolol).
• Clearance of these drugs is affected by hepatic
blood flow. A decreased hepatic blood flow in the
presence of such disease states as cirrhosis and
congestive heart failure is expected to decrease the
clearance of drugs with high extraction ratios.
• Theophylline clearance may decrease by 45% in a
child with acute viral hepatitis.
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21. • Serum drug concentrations should be monitored for
drugs with narrow therapeutic index and eliminated
largely by the kidney (e.g., aminoglycosides and
vancomycin) to optimize therapy in pediatric patients
with renal dysfunction.
• For drugs with wide therapeutic ranges (e.g., penicillins
and cephalosporins), dosage adjustment may be
necessary only in moderate to severe renal failure.
• Renal clearance or rate of elimination is directly
proportional to the glomerular filtration rate, as
measured by endogenous renal creatinine clearance.
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Renal disease :-

22. • Drug therapy in pediatric patients with cystic
fibrosis require increased doses of certain drugs.
• Studies have reported a higher clearance of such
drugs as gentamicin, tobramycin, netilmicin,
amikacin, dicloxacillin, cloxacillin, azlocillin,
piperacillin, and theophylline.
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Cystic Fibrosis:-

23. • Mechanism is not cleared in adverse effect of many
drugs in child. But it may be due to immature p’kinetic
parameters and some medication errors.
• Some well known adverse effect
• Tetracycline  Teeth brown coloration
• Corticosteroids  Growth suppression in Prepubertal
child.
• Paradoxical hyperactivity in child with phenobarbital
treatment
• Aspirin treatment  Reye’s syndrom (Swelling of liver
and brain)
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4. Adverse reaction in therapy :-

24. • Medication errors are also considered as an
important cause of ADRs and should always be
considered as a possible causative factor in
any unexplained situation.
• The incidence of medication errors and the
risk of serious errors occurring in children are
significantly greater than in adults.
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25. • Attention should be given to the formulation, taste,
appearance and ease of administration of
treatment.
• The regimen should be simple
• Many health professionals often counsel the
parents only, rather than involving the child in the
counseling process.
• Where possible, treatment goals should be set in
collaboration with the child.
• Studies have shown that parents consider the 8-10
year age groups the most appropriate at which to
start including the child in the counseling process.
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5. Counseling adherence